CytoDyn Inc.

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CytoDyn, Inc. is a clinical-stage biotechnology company, which focuses on the clinical development of innovative treatments for multiple therapeutic indications based on its product candidate, leronlimab, a novel humanized monoclonal antibody targeting the C-C chemokine receptor type 5. Its pipeline includes Leronlimab Clinical Development Pipeline and Long-Acting CCR5 Inhibitor Development Pipeline. The company was founded by Allen D. Allen on May 2, 2002 and is headquartered in Vancouver, WA.

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NEW YORK--(BUSINESS WIRE)--A group of long-time stockholders (the “Nominating Stockholders”) of CytoDyn Inc. (“CYDY or the “Company) (OTC: CYDY) that has nominated five highly experienced director candidates to serve on the Company's Board of Directors today issued the following statement in response to the highly misleading news release issued this morning by CYDY: “CytoDyn's announcement, laced with scare-mongering hysterics, is another desperate attempt by Nader Pourhassan, his Board, his ma

Group of CytoDyn Stockholders Responds to Highly Misleading Company Release

VANCOUVER, Wash.--(BUSINESS WIRE)--The Board of Directors (the “Board”) of CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, today issued the following statement regarding the continued efforts of an activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group” or the “Group”) to mislead shareholders and engage in an unlawful pro

CytoDyn Provides Update on Rosenbaum/Patterson Group Litigation

CytoDyn Inc said it has received comments from the US Food and Drug Administration (FDA) on the company's recently submitted dose justification report for its Vyrologix (leronlimab-PRO 140) drug, an important component to the company's resubmission of its Biologics License Application (BLA) for HIV. The Vancouver, Washington-based late-stage biotechnology company is working to develop a significant advance in HIV treatment beyond the 'AIDS cocktail' combination of pills that has kept millions of people alive since the mid-1990s.

CytoDyn receives FDA guidance for its HIV Biologics License Application dose justification report

Company Believes All Issues Are Addressable and it Will Be Able to Continue BLA Resubmission

CytoDyn Receives FDA Guidance for its HIV BLA Dose Justification Report

VANCOUVER, Washington--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company, today announced that it has filed a lawsuit in the United States District Court for the District of Delaware against the activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group” or the “Activist Group”). The suit seeks to enjoin the Activist Group from misleading shareholders and waging an illegal proxy contest to take over control

CytoDyn Files Lawsuit Against Rosenbaum/Patterson Activist Group for Misleading Shareholders and Waging an Unlawful Proxy Contest

CytoDyn Inc has announced that Brazil's regulatory authority Agência Nacional de Vigilância Sanitária (ANVISA) has approved its previously submitted clinical trial protocol for its flagship drug candidate leronlimab to start patient enrollment in the CD17 trial for severe coronavirus (COVID-19) patients. The Vancouver, Washington-based late-stage biotechnology company said the academic research organization (ARO) Albert Einstein Israelite Hospital (AEIH), in Brazil will conduct the trial.

CytoDyn gets green signal from Brazil's ANVISA to start Phase 3 trial with leronlimab for severe coronavirus patients

VANCOUVER, Washington--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that Brazil's regulatory authority ANVISA (Agência Nacional de Vigilância Sanitária) has approved the previously submitted clinical trial protocol to commence patient enrollment in its CD17 trial for severe COVID-19 patients. The Academic Research Organ

CytoDyn Receives Clearance from Brazil's ANVISA to Commence Phase 3 Trial for Severe COVID-19 Patients

VANCOUVER, Washington--(BUSINESS WIRE)--CytoDyn Inc. (OTCQB: CYDY) (“CytoDyn” or the “Company”), a late-stage biotechnology company, announced today that the director nominations submitted by an activist group led by Paul Rosenbaum and Bruce Patterson (the “Rosenbaum/Patterson Group”) were invalid. The Rosenbaum/Patterson Group attempted to nominate five director candidates to take over control of the Company's six-member Board of Directors (the “Board”). Like most public companies, CytoDyn's b

CytoDyn Announces That Director Nominations by Rosenbaum/Patterson Activist Group Are Invalid

Paul Rosenbaum, CEO of SWR Corp., is no stranger to shareholder activism. He's leading a group of investors calling for change at CytoDyn.

Large shareholder group calls for a board overhaul at pharma company CytoDyn

VANCOUVER, Washington, July 19, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Christopher Recknor, M.D., Chief Operating Officer and Head of Clinical Development, will host an investment community webcast on Thursday, July 22, 2021.

CytoDyn to Hold Webcast on July 22 to Discuss Results from Cancer Trials, HIV BLA Status, NASH, and COVID-19 Trials

CytoDyn Inc (OTCQB:CYDY) has shared strong preliminary results from its Phase 1b/2 trials and compassionate use study of its flagship drug candidate leronlimab in 30 metastatic triple-negative breast cancer (mTNBC) patients. The leronlimab trial is being carried out in combination with carboplatin for the treatment of metastatic triple-negative breast cancer.

CytoDyn says it has strong preliminary results from 30 metastatic triple-negative breast cancer patients treated with leronlimab

CytoDyn will seek FDA guidance on proceeding with an expedited regulatory plan for approval of leronlimab with existing FDA Fast Track designation for mTNBC CytoDyn will seek FDA guidance on proceeding with an expedited regulatory plan for approval of leronlimab with existing FDA Fast Track designation for mTNBC

CytoDyn Announces Preliminary Results from 30 mTNBC Patients Treated with Leronlimab. Decreases in CAMLs after 4 Doses of Leronlimab were Identified in Over 70% of Patients and were Associated with a 450% Significant Increase in Overall Survival at 12-Mon

CytoDyn Inc (OTCQB:CYDY) has announced that a clinical trial for its flagship drug candidate, leronlimab, has advanced from Phase 1b to a Phase 2 study. The leronlimab trial is being carried out in combination with carboplatin for the treatment of metastatic triple-negative breast cancer (mTNBC).

CytoDyn advances to Phase 2 trial with leronlimab for mTNBC metastatic breast cancer treatment

CytoDyn anticipates preliminary efficacy data regarding potential responders in metastatic triple-negative breast cancer in approximately two weeks

CytoDyn's Trial for Metastatic Triple-Negative Breast Cancer Demonstrates Safety with 350 mg, 525 mg and 700 mg Dosages; Officially Advances to Phase 2 from Phase 1b

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CytoDyn Inc (OTCQB:CYDY) has announced that its flagship drug candidate, leronlimab, has been granted US Patent No. 11,045,546 by the US Patent and Trademark Office (USPTO) for methods of treating coronavirus (COVID-19) infection.

CytoDyn granted important US patent for methods of treating coronavirus infection with leronlimab

VANCOUVER, Washington, July 06, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today its drug candidate, leronlimab, has been granted U.S. Patent No. 11,045,546 by the U.S. Patent and Trademark Office (“USPTO”) for methods of treating coronavirus infection (the “Patent”).

CytoDyn Granted a Significant Patent by USPTO for Methods of Treating Coronavirus Infection with Leronlimab

CytoDyn Inc (OTCQB:CYDY) announced that it has submitted a dose justification report on its Vyrologix (leronlimab-PRO 140) drug to the US Food and Drug Administration (FDA), which will be followed by an official submission for an IND (investigational new drug). The late-stage biotechnology company is developing leronlimab to battle multiple diseases, including coronavirus (COVID-19).

CytoDyn submits dose justification report on Vyrologix for HIV to the US Food & Drug Administration

CytoDyn submits dose justification report on on Vyrologix for HIV to the US Food & Drug Administration

Management works to advance its BLA filing seeking FDA approval for leronlimab as a combination therapy for HIV patients while continuing its evaluation of other potential indications

CytoDyn Submits Dose Justification Report to FDA to Begin Overcoming Deficiencies in its BLA for HIV

NEW YORK--(BUSINESS WIRE)--A group of long-time stockholders (the “Nominating Stockholders”) of CytoDyn Inc. (“CYDY or the “Company) (OTC: CYDY) today announced that it has sent a notice to CYDY nominating five highly experienced director candidates – Thomas Errico, MD, Bruce Patterson, MD, Paul Rosenbaum, Peter Staats, MD and Melissa Yaeger – to serve on the Company's Board of Directors. In the letter to stockholders, the Committee highlights the numerous ill-advised actions taken by CYDY's cu

Group of Cytodyn Stockholders Nominates Five Highly Qualified Director Candidates to Replace Board Responsible for Mismanagement and Value Destruction

CytoDyn Inc (OTCQB:CYDY) has announced encouraging early data from its long-hauler CD15 trial, which aimed to assess leronlimab administered as a weekly injection in people experiencing COVID-19 (coronavirus) symptoms for over 12 weeks.  "We are very pleased with the preliminary results from our long-haulers trial, which showed a greater improvement in the leronlimab patient group over placebo in 18 of 24 COVID-19 symptoms," said Chris Recknor, CytoDyn's chief operating officer.

CytoDyn pleased with preliminary results from long-haulers coronavirus trial

VANCOUVER, Washington, June 21, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY), ("CytoDyn" or the "Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today preliminary results after unblinding the data from its COVID-19 long-haulers clinical trial.

CytoDyn Inc. Announces Positive Preliminary Results of Unblinded Data from Long-Haulers Trial Showing Greater Improvement in Leronlimab Group over Placebo in 18 of 24 Symptoms

VANCOUVER, Washington, June 16, 2021 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTCQB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, announced today Nader Pourhassan, Ph.D., President and Chief Executive Officer, Scott Kelly, M.D., Chairman, Chief Medical Officer and Head of Business Development, and Christopher Recknor, M.D., Chief Operating Officer and Head of Clinical Development, will host an investment community webcast on Monday, June 21, 2021.

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